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Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)

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ClinicalTrials.gov Identifier: NCT01431352
Recruitment Status : Unknown
Verified November 2013 by Xiaoke Wu, Heilongjiang University of Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : September 9, 2011
Last Update Posted : November 5, 2013
Sponsor:
Information provided by (Responsible Party):
Xiaoke Wu, Heilongjiang University of Chinese Medicine

Study Description
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Brief Summary:
This is a multicenter double-blind randomized controlled trial. A total of 420 anovulatory Chinese women with PCOS will be recruited, and the randomization will be stratified by each participating site. Participants will be randomized into one of the two treatment arms: letrozole and CHMG or letrozole and CHMG placebo. CHMG or its placebo will be taken twice a day for up to six months. Letrozole (2.5 mg daily) was given on days 3-7 of the menstrual cycle after a spontaneous period or withdrawal bleeding, and the dose will be increased to 5.0 mg daily during the last three months for non-pregnant women in both groups.The aim of the present study is to determine the efficacy of combined treatment with letrozole and CHMG on improving live birth rates in infertile Chinese women with PCOS. Our hypothesis is that the combination of letrozole and CHMG is more likely to increase the ovulation rate and decrease the miscarriage rate and result in a higher live birth rate in PCOS women than letrozole alone.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Letrozole Drug: Chinese herbal medicine granules or Chinese herbal medicine granules placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Chinese Herbal Medicine and Letrozole on Live Birth in Infertile Women With Polycystic Ovary Syndrome:A Double-blind Randomized Controlled Trial
Study Start Date : September 2009
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Letrozole

Arms and Interventions
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Arm Intervention/treatment
Experimental: Letrozole+ Chinese herbal medicine granules Drug: Letrozole
2.5 mg letrozole daily from day 5 of the menses for 5 days for month 1 to 3, 5.0 mg letrozole daily from day 5 of the menses for 5 days for month 4 to 6.

Drug: Chinese herbal medicine granules or Chinese herbal medicine granules placebo
twice a day for 6 month
Placebo Comparator: Letrozole+ Chinese herbal medicine granules placebo Drug: Letrozole
2.5 mg letrozole daily from day 5 of the menses for 5 days for month 1 to 3, 5.0 mg letrozole daily from day 5 of the menses for 5 days for month 4 to 6.


Outcome Measures
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Primary Outcome Measures :
  1. Live birth rate [ Time Frame: Up to 2 years ]

Secondary Outcome Measures :
  1. Ovulation rate [ Time Frame: Up to 1 year ]
  2. Miscarriage rate [ Time Frame: Up to 1 year ]
  3. Change in hormonal profile [ Time Frame: Up to 1 year ]
    Follicle-stimulating hormone, luteinizing hormone, total testosterone, sex hormone binding globulin, and dehydroepiandrosterone sulphate.

  4. Change in metabolic profile [ Time Frame: Up to 1 year ]
    glucose and insulin concentrations, cholesterol, triglycerides, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol.

  5. Change in physical measurements [ Time Frame: Up to 1 year ]
    weight, vital signs, and hip and waist measurements.

  6. Pregnancy complications [ Time Frame: Up to 1 year ]
    gestational diabetes, pregnancy-induced hypertension, intrauterine growth retardation, ectopic pregnancy, congenital anomaly, preeclampsia, preterm labor, HELLP syndrome, preterm premature rupture of membranes, placental abruption, placenta accreta, placenta previa, postpartum hemorrhage, and others.

  7. Birth defects [ Time Frame: Up to 1 year ]
  8. Safety parameters [ Time Frame: Up to 1 year ]
    renal and liver function tests and complete blood count.

  9. Side effect profile [ Time Frame: Up to 1 year ]
    The major risks to the subject are side effects from letrozole and CHMG and the risks associated with pregnancy.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Chinese women with PCOS. PCOS must have been diagnosed based on the presence of two of the following three Rotterdam criteria : (1) oligomenorrhea, anovulation; (2) hyperandrogenism; and (3) the observation of polycystic ovaries by sonography. Oligomenorrhea is defined as an intermenstrual interval >35 days or <8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval >90 days.
  2. History of at least one year of infertility.
  3. Age between 20 and 40 years old.
  4. Normal semen analysis based on World Health Organization criteria (2010). The husband did not need to sign the consent form because semen analysis is part of the clinical assessment at the sites. A sperm concentration ≥15 × 106/mL and total motility ≥40% in the semen analysis of the husband was required for the woman to be included.
  5. Normal uterine cavity and at least one tube patent upon hysterosalpingography or HyCoSy.

Exclusion criteria

  1. History of significant system diseases such as heart, lung, or kidney diseases.
  2. History of other endocrine disorders.
  3. Use of hormonal therapy, including metformin, in the past 3 months.
  4. Previous sterilization procedures (vasectomy or tubal ligation) that have been reversed.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431352


Contacts
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Contact: Lihui Hou, MD 86-451-82130094 houlihui2007@hotmail.com
Contact: Xiaoke Wu, MD. PhD 86-451-82130094 xiaokewu2002@vip.sina.com

Locations
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Sponsors and Collaborators
Heilongjiang University of Chinese Medicine
More Information
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Responsible Party: Xiaoke Wu, Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital, Heilongjiang University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT01431352    
Other Study ID Numbers: Letrozole
First Posted: September 9, 2011    Key Record Dates
Last Update Posted: November 5, 2013
Last Verified: November 2013
Keywords provided by Xiaoke Wu, Heilongjiang University of Chinese Medicine:
Polycystic ovary syndrome
Randomized controlled trial
Chinese herbal medicine
 Chinese herbal medicine granules
Letrozole
Live birth
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
 Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs